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一项随机、开放标签的 II 期临床试验报告了新辅助洛铂治疗乳腺癌的疗效。

A randomized and open-label phase II trial reports the efficacy of neoadjuvant lobaplatin in breast cancer.

机构信息

Breast Disease Center, Southwest Hospital, Third Military Medical University, Chongqing, 400038, China.

出版信息

Nat Commun. 2018 Feb 26;9(1):832. doi: 10.1038/s41467-018-03210-2.

Abstract

Currently, one sixth of triple-negative breast cancer (TNBC) patients who receive docetaxel (T) and epirubicin (E) as neoadjuvant chemotherapy achieve a pathologic complete response (pCR). This study evaluates the impact of adding lobaplatin (L) to the TE regimen. Here, we show data from 125 patients (63 TE and 62 TEL patients). Four patients did not complete all the cycles. Two-sided P values show that the addition of L (38.7% vs. 12.7%, P = 0.001) significantly increases the rate of pCR in the breast and the axilla (TpCR) and the overall response rate (ORR; 93.5% vs. 73.0%, P = 0.003). The occurrence of grade 3-4 anemia and thrombocytopenia is higher in the TEL group (52.5% vs. 10.0% and 34.4% vs. 1.7% respectively). These results demonstrate that the addition of L to the TE regimen as neoadjuvant chemotherapy improves the TpCR and the ORR rates of TNBC but with increased side effects.

摘要

目前,接受多西他赛(T)和表柔比星(E)作为新辅助化疗的三阴性乳腺癌(TNBC)患者中有六分之一实现了病理完全缓解(pCR)。本研究评估了在 TE 方案中添加洛铂(L)的影响。这里,我们展示了来自 125 名患者(63 名 TE 和 62 名 TEL 患者)的数据。有 4 名患者未完成所有周期。双侧 P 值表明,添加洛铂(38.7%对 12.7%,P=0.001)显著增加了乳房和腋窝的 pCR 率(TpCR)和总缓解率(ORR;93.5%对 73.0%,P=0.003)。TEL 组发生 3-4 级贫血和血小板减少的发生率更高(52.5%对 10.0%和 34.4%对 1.7%)。这些结果表明,在新辅助化疗中,将 L 添加到 TE 方案中可提高 TNBC 的 TpCR 和 ORR 率,但副作用增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e504/5827032/ad0e5e40e74e/41467_2018_3210_Fig1_HTML.jpg

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